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Mediterr J Rheumatol 2022;33(Suppl 1):162-72
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Effectiveness and Safety of Certolizumab Pegol in Axial Spondyloarthritis in a Real-World Setting in Greece: A Sub-Analysis of the Prospective Non-Interventional CIMAX Cohort Study
Gkikas Katsifis1, Athina Theodoridou2, Andreas Bounas3, Panagiotis Georgiou4, Petros Sfikakis5, Kalliopi Fragiadaki5, Theodoros Dimitroulas6, Evangelia Mole7, Lars Bauer8, Thomas Kumke8, Bengt Hoepken8
Authors Information
  1. Rheumatology Clinic, Athens Naval Hospital, Athens, Greece
  2. Euromedica General Clinic of Thessaloniki, Thessaloniki, Greece
  3. Olympion Therapeutirion General Clinic, Patras, Greece
  4. Rheumatology Unit, Agios Andreas Hospital, Patras, Greece
  5. Laikon General Hospital, Athens, Greece
  6. 4th Department of Internal Medicine, Hippokrateion General Hospital of Thessaloniki, School of Medicine, Aristotle University, Thessaloniki, Greece
  7. Evangelismos General Hospital, Athens, Greece
  8. UCB Pharma, Monheim am Rhein, Germany


G Katsifis, A Theodoridou, A Bounas, P Georgiou, P Sfikakis, K Fragiadaki, T Dimitroulas, E Mole, L Bauer, T Kumke, B Hoepken

Abstract

Objectives: We report the effectiveness and safety of certolizumab pegol (CZP) treatment in a real‑world Greek axial spondylarthritis (axSpA) population, including patients with radiographic (r‑axSpA) and non‑radiographic (nr‑axSpA) disease. Methods: We performed a sub‑analysis of the Greek cohort from CIMAX (NCT02354105), a multicentre, non‑interventional cohort study that prospectively investigated CZP treatment in patients with axSpA. The primary outcome was change from baseline (CfB) in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 52. Results: Across 12 sites in Greece, 126 patients (r‑axSpA: 91; nr‑axSpA: 35) received ≥1 dose of CZP and were included in the Safety Set (SS), with 120 patients (r‑axSpA: 86; nr‑axSpA: 34) included in the Full Analysis Set (FAS). The mean (standard deviation [SD]) CfB in BASDAI at Week 52 was –3.8 (2.0) in the overall axSpA population, with numerically greater improvements observed for nr‑axSpA patients compared with r‑axSpA (nr‑axSpA: –4.2 [2.1]; r‑axSpA: –3.7 [2.0]). Improvements in the axSpA population, including r‑axSpA and nr‑axSpA subpopulations, were observed in key secondary and additional outcomes at Week 52. Overall, 14.3% (18/126) of patients in the axSpA population experienced ≥1 adverse event (AE). There were no serious AEs or deaths reported during the study. Conclusions:Patients with r‑axSpA and nr‑axSpA treated with CZP in clinical practice in Greece showed improvements in disease activity and key symptoms. CZP treatment may therefore help address the substantial health burden associated with axSpA in Greece.


Cite this article as: Katsifis G, Theodoridou A, Bounas A, Georgiou P, Sfikakis P, Fragiadaki K, Dimitroulas T, Mole E, Bauer L, Kumke T, Hoepken B. Effectiveness and Safety of Certolizumab Pegol in Axial Spondyloarthritis in a Real-World Setting in Greece: A Sub-Analysis of the Prospective Non-Interventional CIMAX Cohort Study. Mediterr J Rheumatol Mediterr J Rheumatol 2022;33(Suppl 1):162-72.

Article Submitted: 29 Oct 2021; Revised Form: 20 Dec 2021; Article Accepted: 21 Dec 2021; Available Online: 15 Apr 2022

https://doi.org/10.31138/mjr.33.1.162

This work is licensed under a Creative Commons Attribution 4.0 International License.

©Katsifis G, Theodoridou A, Bounas A, Georgiou P, Sfikakis P, Fragiadaki K, Dimitroulas T, Mole E, Bauer L, Kumke T, Hoepken B.

Keywords: axial spondyloarthritis, TNF inhibitor, certolizumab pegol